Kornimate/medical-research-clean huggingface dataset:
a patient handling study of mometasone furoate/formortoral fumarate (mf/f) metered dose inhaler (mdi) with an integrated dose counter in adolescent and adult subjects with asthma or chronic obstructive pulmonary disease (study p04703am1)

Conditions: Asthma; COPD

Summary: this was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (mf/f) metered dose inhaler (mdi) 100/10 micrograms (mcg) twice daily (bid) (2 puffs of mf/f mdi 50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease (copd) of at least 12 months. the primary purpose of the study was to evaluate the performance of the mf/f mdi integrated dose counter under normal patient handling conditions.


Eligibility criteria:
diagnosis and criteria for inclusion: * a participant must have been at least 12 years of age, of either sex, and of any race, with a diagnosis of persistent asthma or copd of at least 12 months. * a participant must have been able to demonstrate correct use of an mdi without a counter at the screening visit. * a participant must have demonstrated at least 90% compliance with completion of the e-diary, use of the counterstrip, and use of the study medication over the 2-week screening period. exclusion criteria: * participants with a serious uncontrolled medical disorder, which in the judgment of the investigator, could have interfered with the study, or required treatment which might interfere with the study. * participants who in the judgment of the investigator and/or sponsor had a significant recent or current, repetitive strain injury (rsi) that may have impacted their ability to effectively participate in the full duration of the study.
dexamethasone for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype

Conditions: Hospital Acquired Pneumonia

Summary: determine the efficacy of dexamethasone plus standard of care (soc) as compared to placebo plus soc for treating severe hospital-acquired pneumonia in critically ill patients with a proinflammatory phenotype; it's an international phase iii, double-blind, placebo-controlled, randomized trial.


Eligibility criteria:
inclusion criteria: * hospital-acquired pneumonia (hap) according to european guidelines (torres et al. eur respir j 2017): association of two criteria among (body temperature \> 38°c, leukocytosis\>12000 cells per ml, leucopenia \<4000 cells per ml and purulent pulmonary secretions), appearance of a new infiltrate or change in an existing infiltrate on chest radiography, and respiratory sample (sputum, aet, bal, mini-bal or blind bal) collected for bacteriological diagnosis (results can be pending at inclusion). the diagnosis of hap can have been made outside of icu. diagnosis is done at least 48 hours after hospital admission. * hap severity defined as a pao2/fio2 ratio \< 200 under invasive mechanical ventilation. * biological systemic inflammatory response defined as cpr\> 150 mg/l (15 mg/dl)\* * receiving curative antimicrobial therapy for the current episode of hap pneumonia for less than 48 hours. * informed consent from a legal representative, or emergency procedure (when possible, according to national regulation, see below). if it is not possible to obtain the patient consent prior the inclusion (comatose patients), patient consent for the study continuation will be obtained as soon as deemed possible. * person insured under a health insurance scheme. * female of childbearing age who agree and who are able to comply with effective contraception for the 28 first days of the study: exclusion criteria: * pregnant women (serum or urine test), breastfeeding women. * patient under legal protection (incl. under guardianship or trusteeship). * hypersensitivity to dexamethasone and hypersensitivity to all of its excipients * ongoing administration of glucocorticoid at the time of randomisation, such as for covid-19 infection requiring supplemental oxygen therapy * severe septic shock (norepinephrine \> 0.4 microg/kg/min and serum lactate level greater than 2 mmol/l) at the time of randomisation * prolonged use of corticosteroids at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for \>3 weeks in the past 60 days * uncontrolled viral (hepatitis,herpes, zona, varicella) or systemic fungal infection * immunosuppression pre-existing to hospitalisation (severe lymphopenia \< 500 lymphocytes/mm3, hematologic cancer, aplasia, chemotherapy/radiotherapy for cancer within 3 months prior to the inclusion, or anti-graft rejection drug). * uncontrolled psychotic disorder (acute or chronical) * patients not expected to survive for more than 48 hours. * participation in another drug clinical trial
hematotoxicity in acute lymphoblastic leukemia children in maintenance phase therapy

Conditions: Acute Leukemia

Summary: this study use an observational study design from patient medical records to obtain data on patient demographics, nutritional status, 6mp dosing, and albumin levels of lla child patients.

all medical record data of lla child patient at maintenance phase therapy, who came to cipto mangunkusumo kiara hospital in period 2014 - 2016. the data that are colected consist of age, gender, disease stratification, nutritional status, the dosage of 6-mp, albumin levels, hemoglobin levels, leukocyite counts, platelet counts, and absolute neutrophil counts.

Eligibility criteria:
medical record of acute limphoblastic leukemia patients at cipto mangunkusumo hospital, in period of 2012 - 2014, with inclusion criteria: * lla patients, male and female, age 1 - \<18 years * received chemotherapy maintenance phase based on indonesian protocol of all - 2013 exclusion criteria: * incomplete medical record data.
rapid medical donation programme for breast cancer

Conditions: Metastatic Breast Cancer

Summary: treatment of breast cancer has traditionally been based on the primary tumour's features in the breast. only recently, when cancer returns at other sites, has there been an attempt to biopsy the metastatic disease and change treatments accordingly. a 'repeat biopsy' can be technically difficult, painful and, when possible, only represents a small sample of one of many metastases. even when one deposit responds to a new treatment, a neighbouring one may continue to grow. there is an urgent need to characterise all deposits, particularly the lethal ones which progress despite all treatments. this study will enable the comprehensive analysis of the metastatic process and the evolution of the breast cancer through the course of its treatment. patients who have consented during life to donate their tissues for molecular analysis will provide the means for such an analysis. main aims: * to comprehensively and systematically examine metastatic breast cancer by its detailed exploratory molecular characterization to elucidate the possible inter- and intratumoural heterogeneity between the primary tumour and the majority of metastatic sites. * to map the natural history of the metastatic breast cancer process


Eligibility criteria:
inclusion criteria: * patients who have completed active treatment (or trials) for metastatic breast cancer. * patients referred to either community or the hospital-based palliative care unit from royal marsden national health service foundation trust. exclusion criteria: * lack of capacity / inability to give informed consent. * diagnosis of alternative cancer within the last 5 years other than resected basal cell skin cancer or cervical intraepithelial neoplasia. * patients known to be hiv, hepatitis b virus or hepatitis c virus positive on serology . * spongiform encephalopathy (known or suspected cjd) . * eligibility for or current participation in a clinical trial (excluding palliative care trials)

Keywords: breast cancer
physiologic indicators for prognosis in abdominal sepsis study

Conditions: Acute Peritonitis; Abdominal Sepsis

Summary: early detection and timely therapeutic intervention can improve the prognosis of patients with sepsis. however, early diagnosis of sepsis can be difficult; because determining which patients presenting with signs of infection during an initial evaluation, do currently have, or will later develop a more serious illness is not easy. physiological deterioration often precedes clinical deterioration as patients develop critical illness. in this study, the investigators aim to evaluate vital signs in a global cohort of patients with acute secondary peritonitis, determining which parameters are statistically significant to predict in-hospital mortality and icu admission.

the study will be a worldwide multicenter observational study. the study will include patients admitted in the surgical department with acute peritonitis during a four-month study period (february 1, 2018 - may 31, 2018). the study will not attempt to change or modify the clinical practice of the participating physicians: neither informed consent or formal approval by local ethics committee will be required because of the purely observational nature of the study. the study will be monitored by the principal investigator, which will investigate and verify missing or unclear data submitted to a central database. the study protocol has been approved by the board of the wses and the study will be conducted under its supervision. the board of the wses grants the proper ethical conduct of the study. the data collection will be anonymous, as well as the name of the patients or hospital will be not collected in the website. every hospital will continue following their ethical standards and local rules. the list of the submitted cases will not be recognized by investigators and linked to the submitting hospital. individual researchers will take personal responsibility of data collection of this study. in each center, the coordinator will collect and fill the data in an online case report system. these data included the following: * patient and disease characteristics * diagnostic profiles * treatment profiles * post-operative course

Eligibility criteria:
inclusion criteria: - clinical diagnosis of acute (secondary) localized or diffuse peritonitis. exclusion criteria: - clinical diagnosis of acute pancreatitis

Keywords: abdominal sepsis secondary peritonitis complicated intra-abdominal infections
cancer patients' performance status assessed using cardiopulmonary exercise testing and wearable data generation

Conditions: Malignant Solid Tumor; Hematologic Malignancies

Summary: the primary objective of this study is to establish the feasibility and value of physical fitness assessment within patients receiving cytotoxic chemotherapy. if successful, this project will establish the groundwork for physical function assessment in larger cancer clinical trials to assist patient selection and evaluation of toxicity and/or response among trial participants.

physical fitness, whether measured by performance capacity or daily activity, can predict risk of toxicity while helping to evaluate toxicity itself in the course of cancer chemotherapy. cytotoxic chemotherapy causes premature aging and frailty in many cancer patients, so measuring and improving physical function may also limit late morbidity and mortality. clinician-rated performance status (cps; e.g., ecog or karnofsky ps) with or without concomitant organ function testing is the usual gold standard for risk prognostication and patient selection in most cancer settings, but cps is subjective, unreliable, and relatively sensitive only for patients with significant functional compromise. objective evaluations of physical function have the potential to augment or even replace cps in the cancer treatment setting.

Eligibility criteria:
inclusion criteria: * patients receiving cytotoxic chemotherapy with at least a 3 week cycle (either adjuvant/curative or palliative) * age ≥ 18, prioritizing patients ≥ 60 years * at least 6 weeks out from surgical resection * presence of working email address * access to internet at home and either access to wireless internet or cellular data reception * ability to read and understand english * ability to understand and comply with study procedures exclusion criteria: * dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent * contraindication to cpet per standard american thoracic society (ats) guidelines
let's get real: family health communication tool in pediatric stem cell transplant and cellular therapy

Conditions: Hematologic Malignancy; Solid Tumor; Sickle Cell Disease; Aplastic Anemia; Immune Deficiency; Metabolic Disorder

Summary: the investigators will conduct a pilot feasibility and efficacy trial of a newly developed family health communication tool (called let's get real) in increasing youth involvement in real-time stem cell transplant and cellular therapy decisions (sctct). the investigators will pilot the intervention among 24 youth and their parents, stratified by youth age (stratum 1, 8-12 years of age and stratum 2, 13-17 years of age).


Eligibility criteria:
inclusion criteria youth: * children or adolescents 8-17 years of age referred for sctct. * diagnosis of malignant or nonmalignant disorder. * referred for any type of sctct. autologous and allogeneic stem cell and cellular therapies are eligible. * planning to meet with a provider to discuss sctct. * must have the ability to understand and willingness to consent to participate after reviewing an irb approved informed assent document. * must speak english and be cognitively able to participate. inclusion criteria parents: * parent or guardian of a child 8-17 years of age with any diagnosis referred for any type of sctct. diagnoses may include malignant and nonmalignant disorders. autologous and allogeneic stem cell and cellular therapies are eligible. parent or guardian is defined as an adult who usually cares for the youth and has authority to make medical decisions for them. * must have the ability to understand and willingness to consent to participate after reviewing an irb approved informed consent document. * must speak english and be cognitively able to participate. exclusion criteria youth: * active medical problems severe enough to preclude study participation at the time of recruitment. * patients who are otherwise eligible, but whose primary transplant physician does not want them to participate in the study. * lacks cognitive capacity to complete study activities, as determined by consenting professional. exclusion criteria parents: * their youth referred for sctct does not assent to participate.

Keywords: pediatric family decision making health communication intervention
safety and efficacy of sequential cd19 and cd22 targeted car-t therapy for relapsed/refractory b cell lymphoma

Conditions: Lymphoma, B-Cell

Summary: this is a single arm study to evaluate the efficacy and safety of sequential cd19 and cd22 targeted car-t cells therapy for patients with relapsed/refractory b cell lymphoma.

although the cd19 targeted car-t cell therapies have gained significant results in patients with relapsed and refractory b-cell leukemia and lymphoma. there are some patients who resisted anti-cd19 car-t cells or get cd19 negative relapse. to make further improvement, we launch such a clinical trial using sequential cd19 and cd22 targeted car-t cells for patients with relapsed and refractory b cell lymphoma to evaluate the efficacy and safety of sequential cd19 and cd22 targeted car-t cell therapy.

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory b cell non-hodgkin lymphoma. 2. kps\>60. 3. life expectancy\>12 weeks. 4. gender unlimited, age from 3 years to 70 years. 5. evidence for cell membrane cd19 and/or cd22 expression; 6. patients who have failed at least one line of a standard treatment. 7. no serious mental disorder. 8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(cr≤133umol/l). 9. no other serious diseases(autoimmune disease, immunodeficiency etc.). 10. no other tumors. 11. patients volunteer to participate in the research. 12. patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active gvhd and no longer taking immunosuppressive agents for at least 30 days prior to trial exclusion criteria: 1. pregnancy and nursing females. 2. patients are allergic to cytokines. 3. uncontrolled active infection. 4. acute or chronic gvhd. 5. treated with t cell inhibitor. 6. patients who had used steroid hormones within one week. 7. patients who had used rituximab within two weeks. 8. hiv/hbv/hcv infection. 9. other situations we think improper for the research.

Keywords: car-t lymphoma
intraocular pressure with loteprednol and dexamethasone

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: the purpose of this study is to compare intraocular pressure (iop) changes after pterygium surgery among patients using loteprednol and dexamethasone during the postoperative period.

surgical management of pterygium is known to initiate an inflammatory process with different levels of intensity. corticosteroids are anti-inflammatory agents used to reduce the inflammatory process observed after surgical interventions including after pterygium surgery. however, use of topical corticosteroids can induce an elevation in intraocular pressure (iop) due to a reduction in the facility of aqueous outflow. loteprednol etabonate (le) was designed to maintain the anti-inflammatory efficiency of corticosteroids while lowering the risk of inducing iop elevation. le showed less effect on iop than prednisolone acetate. this probably occurs due to lower levels of le in the aqueous humor. some trials compare le to other corticosteroids or placebo in treatments of the anterior uveitis, allergic conjunctivitis and cataract surgery. to our knowledge, there are no trials studying the effect of le on iop after pterygium surgery.

Eligibility criteria:
inclusion criteria: * age: eighteen years old or more * iop: less than 22mmhg exclusion criteria: * history of previous ocular surgery * use of topical or systemic corticosteroids for up to a month before the surgery * extensive pterygia that disabled accurate iop measurement

Keywords: intraocular pressure pterygium surgery steroids glaucoma
nashville early diagnosis lung cancer project

Conditions: Lung Cancer

Summary: this screening study will address the lack of molecular strategies for the early detection of lung cancer and integrate those with epidemiological and imaging strategies. the hypothesis is that the repeated measure of biomarkers of risk obtained from the molecular analysis of biological specimens including those from bronchoscopy (bronchial brushings and biopsies) may contribute to the refinement of high-risk populations and allow an earlier clinical diagnosis. the goal of the investigators study is to provide screening for lung cancer in a high-risk population. in this prospective cohort it will be tested whether repeated measure of biomarkers of risk allows early detection of lung cancer.

it is proposed to test the hypotheses in a screening study of high risk individuals (characterized by an established prediction rule). the expected prevalence of lung cancer in this high risk group is estimated to be 2% per year. all individuals benefit from clinic visit, low-dose chest ct, spirometry and auto-fluorescence bronchoscopy at baseline, chest ct, follow-up doctor visit, and auto-fluorescence bronchoscopy at least at year 2 and 5.

Eligibility criteria:
inclusion criteria: * 55 - 80 years of age * current smoker or former smoker. if former smoker, must have quit smoking less than 15 years ago * \>/= 30 pack year of smoking history exclusion criteria: * history of diagnosis/treatment of lung cancer in the past 2 years * history of head/neck or esophageal cancer in the last 1 year * inability to provide informed consent * participants in whom stopping anti-platelet or anti-coagulation therapy would have an adverse effect (dvt, mechanical heart valves, unstable coronary syndrome, etc.)
study on the value of three-dimensional speckle tracking technique

Conditions: Echocardiography, Three-Dimensional; Coronary Artery Disease

Summary: for a long time, it has been hoped that doctors could screen and diagnosis of coronary heart disease through non-invasive imaging techniques, so as to maximize the benefit/risk ratio of patients. this trial is to explore the screening and diagnostic value of three-dimensional speckle tracking technology for coronary heart disease, and the evaluation value of 3d speckle track image(3d-sti) technology for cardiac function improvement after coronary intervention, and to seek reliable, accurate and quantifiable non-invasive imaging examination for the diagnosis, follow-up and prognosis of coronary heart disease. in this study, coronary angiography is taken as the "gold standard", and 3d-sti echocardiography technology is proposed to combine with clinical characteristics of subjects for joint diagnosis, so as to evaluate the value of 3d-sti technology in the diagnosis of coronary heart disease. patients were followed up with echocardiography after interventional treatment to explore the feasibility of 3d-sti technology in evaluating cardiac function improvement.


Eligibility criteria:
inclusion criteria: * patients diagnosed with coronary heart disease * patients underwent coronary angiography with or without pci exclusion criteria: * patients with non-sinus rhythm * patients with severe heart valvular disease * patients with severe cardiomyopathy * patients with congenital heart disease * patients with severe heart failure stage * patients with acute myocardial infarction occurred during follow-up * patients with other extremely severe illness * patients whose images are not clear enough to mark the endocardium
regorafenib post-marketing surveillance

Conditions: Colorectal Neoplasms

Summary: this study is a regulatory post-marketing surveillance in japan, and it is a local prospective and observational study of patients who have received regorafenib for colorectal cancer. the objective of this study is to assess safety and effectiveness of regorafenib using in real clinical practice. a total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. at 12 months after the first administration of regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.


Eligibility criteria:
inclusion criteria:patients * who are determined to start regorafenib/ stivarga treatment exclusion criteria: * patients who have previously received regorafenib/ stivarga

Keywords: regorafenib colorectal neoplasms